Acupuncture for Dry Eye Syndrome

NCT00969280 | Completed Phase 3 Results DMC

• 1 other identifier: KI0906
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.

Conditions

Dry Eye Syndromes

Keywords

Acupuncture; Dry eye syndrome; Ocular Surface Disease Index; Schirmer test; Tear film Break-up time

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index : OSDI

  The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.

  Visit 11 (after 3 weeks from baseline)

Secondary Outcomes (5)

• Visual Analogue Scale of Self Symptoms

  every visit

• Schirmer 1 Test

  visit 1,10

• Tear Film Break-up Time : BUT

  Visit 1, 10

• Medication Quantification Scale (MQS)

  every visit

• General Assessment

  visit 11

Study Arms (2)

Standardized Acupuncture group

EXPERIMENTAL

Device: Standardized Acupuncture

Non-acupoint shallow penetration group

PLACEBO COMPARATOR

Device: Non-acupuncture point shallow penetration acupuncture

Interventions

Standardized Acupuncture DEVICE

Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks. According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20\*30mm (Dongbang Co., korea) acupuncture needle. All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes.

Standardized Acupuncture group

Non-acupuncture point shallow penetration acupuncture DEVICE

Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks. Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20\*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes.

Non-acupoint shallow penetration group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:
• Patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
• Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test

You may not qualify if:

• Those who have defects of eyelid or eyelashes
• Those who have acute infection of eyelid, eyeball or accessories of eye
• Those who have Stevens-Johnson syndromes or Pemphigoids
• Those who have Vitamin A deficiency
• Those who have any defects of eye or accessories of eye by external injuries
• Those who have undergone any surgical operation for eye during last 3 months
• Those who are using contact lens
• Those who have any difficulties about eye opening or eye closing due to facial palsy
• Those who have undergone punctual occlusion surgery
• Those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops)
• Those who have systemic immune therapy
• Those who are pregnant or have any plan for pregnancy
• Those who are not appropriate to this study by investigators decision

Sponsors & Collaborators

• Korea Institute of Oriental Medicine: lead

Study Sites (1)

Clinical Research Center, Korea institute of oriental medicine

Daejeon, Chongchungdo, 302-869, South Korea

Location

Related Publications (1)

• Kim TH, Kim JI, Shin MS, Lee MS, Choi JY, Jung SY, Kim AR, Seol JU, Choi SM. Acupuncture for dry eye: a randomised controlled trial protocol. Trials. 2009 Dec 3;10:112. doi: 10.1186/1745-6215-10-112.

  PMID: 19958541 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Tae-Hun Kim, Researcher
• Organization: Korea Institute of Oriental Medicine

rockandmineral@gmail.com

82-10-6532-5524

Study Officials

• Sunmi Choi, doctor

  Korea Institute of Oriental Medicine

  STUDY DIRECTOR

• Taehun Kim, Doctor

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

• Mi-suk Shin, Master

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 21, 2010
• Results First Posted: September 20, 2010

Record last verified: 2010-09

Locations

KR (1)